Adjustable annuloplasty device with alternating peaks and troughs

ABSTRACT

Apparatus is provided, comprising a ring, comprising a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut having a first end-portion and a second end-portion, each peak defined by convergence of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of adjacent second end-portions. The apparatus also comprises a plurality of anchors. Each anchor has a longitudinal axis, is configured to be driven along the longitudinal axis into tissue of the heart, and is coupled to the ring at a respective trough in a manner that facilitates (i) movement of the anchor along the longitudinal axis with respect to the trough, and (ii) deflection of the longitudinal axis with respect to the trough.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority from UK Patent ApplicationGB1611910.9, filed Jul. 8, 2016, and entitled “ADJUSTABLE ANNULOPLASTYDEVICE WITH ALTERNATING PEAKS AND TROUGHS,” which is incorporated hereinby reference.

FIELD OF THE INVENTION

The present invention relates in general to valve repair. Morespecifically, the present invention relates to repair of a cardiac valveof a patient using an adjustable implant.

BACKGROUND

Dilation of the annulus of atrioventricular heart valves, such as themitral valve, prevents the valve leaflets from coating effectively whenthe valve is closed, thereby resulting in regurgitation of blood fromthe ventricle through the valve into the atrium. Annuloplasty is a knownsurgical technique for treatment of a dilated valve annulus. U.S. Pat.No. 9,180,005 to Lashinski et al., which is incorporated herein byreference, relates to an adjustable mitral valve ring forminimally-invasive delivery.

SUMMARY OF THE INVENTION

Annuloplasty implants are described, which are configured to bepercutaneously (e.g., transluminally) delivered to the heart, andadjusted in order to reshape the valve annulus. The anchors comprise aring and tissue anchors for anchoring the ring to the valve annulus. Forsome applications, the implants facilitate deflection or pivoting of thetissue anchors with respect to the ring. For some applications, theimplants comprise a plurality of subunits that are individuallyadvanceable and anchorable to the valve annulus. Once at the valve, thesubunits are connected to form a ring, and the ring is adjusted toreshape the valve annulus.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use at a valve of a heart of a subject,the apparatus including:

a ring, including a plurality of struts arranged in a pattern ofalternating peaks and troughs,

-   -   each strut having a first end-portion and a second end-portion,    -   each peak defined by convergence of adjacent first end-portions        disposed at an angle with respect to each other, and    -   each trough defined by convergence of adjacent second        end-portions; and

a plurality of anchors, each anchor:

-   -   having a longitudinal axis,    -   configured to be driven along the longitudinal axis into tissue        of the heart,    -   coupled to the ring at a respective trough in a manner that        facilitates:        -   movement of the anchor along the longitudinal axis with            respect to the trough, and        -   deflection of the longitudinal axis with respect to the            trough.

In an application, the apparatus further includes at least one anchordriver, couplable to the plurality of anchors, and configured to anchorthe ring to the heart by moving each anchor along its longitudinal axiswith respect to its respective trough.

In an application:

the ring further includes a plurality of adjustment elements, and

each adjustment element is movably coupled to respective adjacent firstend-portions such that movement of the adjustment element with respectto the adjacent first end-portions changes the angle at which theadjacent first end-portions are disposed with respect to each other.

In an application, the apparatus further includes at least oneadjustment tool, reversibly couplable to the plurality of adjustmentelements, and configured to move each adjustment element with respect toits respective adjacent first end-portions.

In an application, the adjustment tool is configured to rotate eachadjustment element with respect to its respective adjacent firstend-portions.

In an application, each adjustment element circumscribes both of therespective adjacent first end-portions.

In an application, the apparatus further includes at least oneadjustment tool, reversibly couplable to the plurality of adjustmentelements, and configured to rotate each adjustment element around bothof its respective adjacent first end-portions.

In an application:

the ring includes a plurality of hinges,

at least one hinge of the plurality of hinges is disposed at eachtrough, and

at each trough, the respective anchor is coupled to the ring via the atleast one hinge.

In an application, each hinge couples the adjacent second end-portionsto each other.

In an application, each hinge is a flexure bearing.

In an application, each hinge includes a fabric.

In an application, each anchor is shaped and rotatably coupled to thering at the respective trough such that rotation of the respectiveanchor with respect to the ring moves the anchor along its longitudinalaxis with respect to the trough.

In an application:

the ring includes a plurality of anchor mounts,

at each trough:

-   -   a respective anchor mount of the plurality of anchor mounts is        articulatably coupled (i) to one second end-portion via a first        hinge of the plurality of hinges, and (ii) to another second        end-portion via a second hinge of the plurality of hinges, and    -   the respective anchor is rotatably coupled to the respective        anchor mount.

In an application, at each trough the respective anchor is rotatablycoupled to the respective anchor mount such that rotation of therespective anchor with respect to the respective anchor mount moves theanchor along its longitudinal axis with respect to the anchor mount.

There is further provided, in accordance with an application of thepresent invention, a method for use with a valve of a heart of asubject, the method composing:

transfemorally delivering a plurality of subunits to the heart, each ofthe subunits including a pair of struts that includes a first strut anda second strut, each strut of the pair having a first end-portion and asecond end-portion, each of the subunits defining a trough at which thesecond end-portion of each strut of the pair is coupled to the secondend-portion of the other strut of the pair;

for each subunit, anchoring the trough to tissue that surrounds thevalve by driving a tissue anchor into the tissue;

securing the first end-portion of the second strut of a first subunit tothe first end-portion of the first strut of a second subunit such thatthe secured first end-portions converge at an angle to define a peak;and

subsequently to the steps of anchoring and securing, reducing the angleof each peak by actuating a respective adjustment element.

In an application, transfemorally delivering the plurality of subunitsto the heart includes:

transfemorally delivering the first subunit to the heart while alongitudinal guide member is coupled to the first-end portion of thesecond strut of the first subunit;

transfemorally delivering the second subunit to the heart; and

subsequently, guiding the second subunit toward the first subunit bysliding the first end-portion of the first strut of the second subunitover and along the longitudinal guide member to the first-end portion ofthe second strut of the first subunit.

In an application, the method includes forming a ring from the pluralityof subunits.

In an application, actuating the respective adjustment element includesrotating the respective adjustment element with respect to therespective peak.

In an application, the method further includes, subsequently to the stepof anchoring, coupling the respective adjustment elements to the firstend-portions that define each peak.

In an application, coupling the respective adjustment elements to thefirst end portions that define each peak includes coupling therespective adjustment elements to the first end portions that defineeach peak subsequently to securing the step of securing.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-D are schematic illustrations of a prior art implant for use ata valve of a heart of a subject, in accordance with some applications ofthe invention;

FIGS. 2A-B, 3A-B, and 4 are schematic illustrations of respectiveimplants for use at a valve of a heart of a subject, in accordance withsome applications of the invention;

FIGS. 5 and 6A-B are schematic illustrations of compressed states ofimplants, in accordance with some applications of the invention;

FIG. 7 is a schematic illustration of an implant in its compressedstate, in accordance with some applications of the invention;

FIG. 8 is a schematic illustration of a system that comprises animplant, in accordance with some applications of the invention; and

FIGS. 9A-J are schematic illustrations of a system that comprises aplurality of subunits that are intracorporeally assembled to form animplant, in accordance with some applications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-D, which are schematic illustrations of aprior art implant 20 shown in U.S. Pat. No. 9,180,005, for use at avalve (e.g., a mitral valve) of a heart of a subject, in accordance withsome applications of the invention. Implant 20 comprises a ring 22 and aplurality of (e.g., 8) anchors 24. Ring comprises a plurality of struts32 arranged in a pattern of alternating peaks 34 and troughs 36 (e.g.,in a zig-zag pattern). Each strut 32 has a first end-portion 32 a and asecond end-portion 32 b. Each peak 34 is defined by convergence ofadjacent first end-portions 32 a (i.e., of first end-portions 32 a ofadjacent struts 32), and each trough 36 is defined by convergence ofadjacent second end-portions 32 b (i.e., of second end-portions 32 b ofadjacent struts 32).

Each anchor 24 has a longitudinal axis ax1 along which it is configuredto be driven into tissue of the annulus of the valve of the heart of thesubject, and is coupled to ring 22 at a respective trough 36 in a mannerthat facilitates movement of the anchor along the longitudinal axis withrespect to the trough. At each trough 36, ring 22 defines a plurality ofholes 38 through which anchor 24 is moveable. Each anchor 24 comprises ahelical tissue-engaging element 26, and an anchor head 28, and is shapedand rotatably coupled to ring 22 at the respective trough 36 such thatrotation of the anchor with respect to the ring moves the anchor alongits longitudinal axis with respect to the trough (e.g., corkscrews theanchor through holes 38 such that the anchor moves longitudinally). Thisis illustrated by FIGS. 1B-C, which show anchors 24 in a retractedposition (FIG. 1B), and in an extended position after having moved alongaxis ax1 with respect to its respective trough 36 (FIG. 1C).

Implant 20 comprises an adjustment element 42 for each pair of adjacentfirst-end portions 32 a. Adjustment element 42 is typically aninternally-threaded nut that screws onto an external thread 44 (visiblein FIG. 1D) defined by the adjacent first-end portions 32 a. Suchadjustment elements are actuated by rotation (e.g., using an adjustmenttool, not shown), and as the adjustment elements are screwed furtheronto and over struts 32, the angle alpha_1 at which first end-portions32 a converge becomes smaller.

Implant 20 is an annuloplasty device, and is delivered to the heartpercutaneously while in a compressed state, via a catheter 40 (FIG. 1A).Within the heart (e.g., within an atrium, such as the left atrium)implant 20 is deployed from the catheter, and automatically expands intoan expanded state (FIG. 1B). While in its expanded state, implant 20 isanchored to tissue of the annulus of the valve by driving the anchorsalong axis ax1 and into the tissue (FIG. 1C). Typically, implant 20 ispositioned such that ring 22 surrounds the orifice of the valve. Onceimplant 20 is anchored, it is contracted by actuating adjustmentelements 42, such that angle alpha_1 is reduced (compare FIG. 1C to FIG.1D). Contraction of implant 20 reduces (i) the circumference and thediameter of ring 22, (ii) the distance between adjacent and oppositeanchors 24, and thereby (iii) the circumference and the diameter of thevalve of the heart, thereby improving function of the valve.

Reference is now made to FIGS. 2A-B, 3A-B, and 4, which are schematicillustrations of respective implants for use at a valve of a heart of asubject, in accordance with some applications of the invention. FIGS.2A-B show an implant 120, FIGS. 3A-B show an implant 220, and FIG. 4shows an implant 320. Unless noted, the structure, function, and use ofimplants 120, 220, and 320 are similar to those of implant 20. Unlessnoted, the components of implants 120, 220 and 320 generally correspondto identically-named components of implant 20, mutatis mutandis. Thereference numerals assigned to the components of implants 120, 220 and320 are intended to further illustrate this relationship. For example,struts 132 of implant 120 generally correspond to struts 32 of implant20, mutatis mutandis (as do struts 232 of implant 220, and struts 332 ofimplant 320). Implants 120, 220, and 320 are typically deliveredtransluminally (e.g., transfemorally).

Implant 120 (FIGS. 2A-B) comprises a ring 122 and a plurality of anchors124. Ring 122 comprises a plurality of struts 132 arranged in a patternof alternating peaks 134 and troughs 136 (e.g., in a zig-zag pattern).Each strut 132 has a first end-portion 132 a and a second end-portion132 b. Each peak 134 is defined by convergence of adjacent firstend-portions 132 a (i.e., of first end-portions 132 a of adjacent struts132), and each trough 136 is defined by convergence of adjacent secondend-portions 132 b (i.e., of second end-portions 132 b of adjacentstruts 132). Similarly to implant 20, implant 120 comprises anadjustment element 142 for each pair of adjacent first-end portions 132a.

Each anchor 124 has a longitudinal axis ax2 along which it is configuredto be driven into tissue of the annulus of the valve of the heart of thesubject, and is coupled to ring 122 at a respective trough 136 in amanner that facilitates movement of the anchor along the longitudinalaxis with respect to the trough. At each trough 136, ring 122 defines aplurality of holes 138 through which anchor 124 is moveable. Typically,each anchor 124 comprises a helical tissue-engaging element and ananchor head (e.g., as described for anchor 24) and is shaped androtatably coupled to ring 122 at the respective trough 136 such thatrotation of the anchor with respect to the ring moves the anchor alongits longitudinal axis with respect to the trough (e.g., corkscrews theanchor through holes 138 such that the anchor moves longitudinally).

In contrast to anchors 24 of implant 20, anchors 124 of implant 120 arecoupled to ring 122 at respective troughs 136 in a manner thatfacilitates both (i) movement of the anchor along axis ax2 with respectto the trough, and (ii) deflection of axis ax2 with respect to thetrough. That is, as well as moving axially, each anchor 124 can deflectwith respect to ring 122 (e.g., with respect to struts 132 thereof). Itis hypothesized by the inventors that this facilitates anchoring ofimplant 120 to the annulus, e.g., by allowing independent orientation ofeach anchor according to the tissue to which it is to be anchored.

Typically, and as shown, implant 120 (e.g., ring 122 thereof) comprisesa plurality of hinges 150, at least one of which is disposed at eachtrough 136, and the anchor 124 disposed at that trough is coupled toring 122 via the hinge. Hinge 150 may be a barrel hinge (e.g.,comprising a pin 151, as shown), a flexure bearing, or any othersuitable hinge type. For some applications, and as shown, the at leastone hinge 150 of each trough 136 couples, to each other, the adjacentsecond end-portions 132 b that define that trough. Alternatively, theadjacent second end-portions 132 b may be coupled independently of theat least one hinge 150, and the at least one hinge couples anchor 124 tothe trough independently of the coupling between the adjacent secondend-portions (embodiment not shown).

For some applications, and as shown, implant 120 (e.g., ring 122thereof) comprises, at each trough 136, an anchor mount 152 that isarticulatably coupled to struts 132 (e.g., to second end-portions 132b), e.g., via the at least one hinge 150. Typically, each anchor mount152 is coupled to one second end-portion 132 b via one hinge 150, and toanother second end-portion 132 b via another hinge. Anchor mount 152defines the holes 138 of implant 120.

FIG. 2A shows implant 120, with a magnification of a trough 136, and afurther magnification of a hinge 150. FIG. 2B illustrates thearticulation, at a trough 136, between ring 122 and an anchor 124 (e.g.,via the articulated coupling between an anchor mount 152 and struts132).

Implant 220 (FIGS. 3A-B) comprises a ring 222 and a plurality of anchors224. Similar to rings 22 and 122, ring 222 comprises a plurality ofstruts 232 arranged in a pattern of alternating peaks (not shown) andtroughs 236 (e.g., in a zig-zag pattern). Each strut 232 has a firstend-portion (not shown) and a second end-portion 232 b. Each peak isdefined by convergence of adjacent first end-portions (i.e., of firstend-portions of adjacent struts 232), and each trough 236 is defined byconvergence of adjacent second end-portions 232 b (i.e., of secondend-portions 232 b of adjacent struts 232). Similarly to implants 20 and120, implant 220 comprises an adjustment element (not shown) for eachpair of adjacent first-end portions.

Each anchor 224 has a longitudinal axis ax3 along which it is configuredto be driven into tissue of the annulus of the valve of the heart of thesubject, and is coupled to ring 222 at a respective trough 236 in amanner that facilitates movement of the anchor along the longitudinalaxis with respect to the trough. At each trough 236, ring 222 defines aplurality of holes 238 through which anchor 224 is moveable. Typically,each anchor 224 comprises a helical tissue-engaging element and ananchor head (e.g., as described for anchor 24) and is shaped androtatably coupled to ring 222 at the respective trough 236 such thatrotation of the anchor with respect to the ring moves the anchor alongits longitudinal axis with respect to the trough (e.g., corkscrews theanchor through holes 238 such that the anchor moves longitudinally).

In contrast to anchors 24 of implant 20, and similarly to anchors 124 ofimplant 120, anchors 224 of implant 220 are coupled to ring 222 atrespective troughs 236 in a manner that facilitates both (i) movement ofthe anchor along axis ax3 with respect to the trough, and (ii)deflection of axis ax3 with respect to the trough. That is, as well asmoving axially, each anchor 224 can deflect with respect to ring 222(e.g., with respect to struts 232 thereof). It is hypothesized by theinventors that this facilitates anchoring of implant 220 to the annulus,e.g., by allowing independent orientation of each anchor according tothe tissue to which it is to be anchored.

Typically, and as shown, implant 220 (e.g., ring 222 thereof) comprisesa plurality of hinges 250, at least one of which is disposed at eachtrough 236, and the anchor 224 disposed at that trough is coupled toring 222 via the hinge. Hinge 250 comprises a flexible strip 251, suchas a strip of fabric. It is to be noted that although this element isnamed a “strip,” and is shown having a width that is greater than itsthickness, and a length that is greater than its width, the term “strip”(including the specification and the claims) is not intended to limitthis element to such dimensions. For some applications, and as shown,the at least one hinge 250 of each trough 236 couples, to each other,the adjacent second end-portions 232 b that define that trough.Alternatively, the adjacent second end-portions 232 b may be coupledindependently of the at least one hinge 250, and the at least one hingecouples anchor 224 to the trough independently of the coupling betweenthe adjacent second end-portions (embodiment not shown).

For some applications, and as shown, implant 220 (e.g., ring 222thereof) comprises, at each trough 236, an anchor mount 252 that isarticulatably coupled to struts 232 (e.g., to second end-portions 232b), e.g., via the at least one hinge 250. Typically, each anchor mount252 is coupled to one second end-portion 232 b via one hinge 250, and toanother second end-portion 232 b via another hinge. Anchor mount 252defines the holes 238 of implant 220.

For some applications, hinge 250 provides a further degree of movementcompared to hinge 150 of implant 120. For example, due to theflexibility of the flexible strip, anchor mount 252 may be twistedand/or deflected asymmetrically with respect to struts 232.

FIG. 3A shows a magnification of a trough 236 of implant 220 (implant220 is not shown in its entirety), and a further magnification of ahinge 250. FIG. 3B illustrates articulation, at a trough 236, betweenring 222 and an anchor 224 (e.g., via the coupling between an anchormount 252 and struts 232).

Implant 320 (FIG. 4) comprises a ring 322 and a plurality of anchors324. Similar to rings 22, 122, and 222, ring 322 comprises a pluralityof struts 332 arranged in a pattern of alternating peaks (not shown) andtroughs 336 (e.g., in a zig-zag pattern). Each strut 332 has a firstend-portion (not shown) and a second end-portion 332 b. Each peak isdefined by convergence of adjacent first end-portions (i.e., of firstend-portions of adjacent struts 332), and each trough 336 is defined byconvergence of adjacent second end-portions 332 b (i.e., of secondend-portions 332 b of adjacent struts 332). Similarly to implants 20,120, and 220, implant 320 comprises an adjustment element (not shown)for each pair of adjacent first-end portions.

Each anchor 324 has a longitudinal axis ax4 along which it is configuredto be driven into tissue of the annulus of the valve of the heart of thesubject, and is coupled to ring 322 at a respective trough 336 in amanner that facilitates movement of the anchor along the longitudinalaxis with respect to the trough. At each trough 336, ring 322 defines atleast one hole through which anchor 324 is moveable. Typically, eachanchor 324 comprises a helical tissue-engaging element and an anchorhead (e.g., as described for anchor 24) and is shaped and rotatablycoupled to ring 322 at the respective trough 336 such that rotation ofthe anchor with respect to the ring moves the anchor along itslongitudinal axis with respect to the trough (e.g., corkscrews theanchor through the hole such that the anchor moves longitudinally).

In contrast to anchors 24 of implant 20, and similarly to anchors 124 ofimplant 120 and anchors 224 of implant 220, anchors 324 of implant 320are coupled to ring 322 at respective troughs 336 in a manner thatfacilitates both (i) movement of the anchor along axis ax4 with respectto the trough, and (ii) deflection of axis ax4 with respect to thetrough. That is, as well as moving axially, each anchor 324 can deflectwith respect to ring 322 (e.g., with respect to struts 332 thereof). Itis hypothesized by the inventors that this facilitates anchoring ofimplant 320 to the annulus, e.g., by allowing independent orientation ofeach anchor according to the tissue to which it is to be anchored.

Typically, and as shown, implant 320 (e.g., ring 322 thereof) comprisesa plurality of hinges 350, each hinge disposed at a respective trough336, and the anchor 324 disposed at that trough is coupled to ring 322via the hinge. Hinge 350 comprises a flexible strip 351, such as a stripof fabric. For some applications, and as shown, the hinge 350 of eachtrough 336 couples, to each other, the adjacent second end-portions 332b that define that trough. Alternatively, the adjacent secondend-portions 332 b may be coupled independently of the at least onehinge 350, and the at least one hinge couples anchor 324 to the troughindependently of the coupling between the adjacent second end-portions(embodiment not shown).

In contrast to implant 220, implant 320 (e.g., ring 322 thereof)typically does not comprise distinct anchor mount. Rather, anchor 324passes directly through flexible strip 351, and the flexible stripserves as an anchor mount 352, as well as providing the articulationfunctionality of hinge 350. Strip 351 thereby defines the hole of eachtrough 336 of implant 320.

For some applications, hinge 350 provides a further degree of movementcompared to hinge 150 of implant 120. For example, due to theflexibility of the flexible sheet or strip, anchor 324 may be twistedand/or deflected asymmetrically with respect to struts 332.

FIG. 3A shows a magnification of a trough 336 of implant 320 (implant320 is not shown in its entirety). FIG. 3B illustrates articulation, ata trough 336, between ring 322 and an anchor 324.

Reference is made to FIGS. 5, and 6A-B, which are schematicillustrations of compressed states of implants, in accordance with someapplications of the invention. Implant 20 is used as an example, but thecompressed states may apply to the other implants described herein. FIG.5 shows a partial side view and a top view of implant 20 in itscompressed state, e.g., as it would be while disposed within catheter40, e.g., as shown in FIG. 1A. (The partial side view is taken from U.S.Pat. No. 9,180,005, whereas the top view is based on the inventors'understanding of that reference.) Adjustment elements 42 are disposed atthe same longitudinal position on the implant as each other, and becausethey are wider than the strut-pairs to which they are coupled, they abuteach other, and effectively define the widest part of implant 20 in itscompressed state. The diameter of implant 20 at this widest part isshown as d1.

FIGS. 6A and 6B show alternative arrangements of adjustment elements 42in alternative compressed states of implant 20. FIG. 6A shows adjustmentelements 42 arranged in an alternating up-down pattern, and FIG. 6Bshows the adjustment elements arranged in two sets of four steps. Bothof these arrangements allow better compression of implant 20, such thatthe implant has a diameter d2 or d3 that is smaller than diameter d1. Itis to be noted that diameters d2 and d3 are typically smaller than thediameter of a circle formed when all the adjustment elements 42 arearranged in a circle, touching each other.

Reference is made to FIG. 7, which is a schematic illustration of animplant in its compressed state, in accordance with some applications ofthe invention. Implant 20 is used as an example, but the compressedstate may apply to the other implants described herein. As describedhereinabove, in a prior art technique, when implant 20 is deployed fromcatheter 40, it automatically expands into an expanded state. For such atechnique, adjustment elements 42 are positioned such that they allowmaximal or near-maximal expansion of ring 22 upon deployment of implant20—e.g., at or close to peaks 34, and/or at or close to an upstream endof threads 44. In the technique of FIG. 7, adjustment elements 42 arepositioned such that the restrict expansion of ring 22 upon deploymentof implant 20—e.g., closer toward (e.g., at or close to) the downstreamend of threads 44. Thus, upon deployment of implant 20 from catheter 40,the implant doesn't automatically expand (or at least not fully). Theoperator may then expand implant 20 in a controlled and/or stepwisemanner by actuating adjusting elements 42 (e.g., such that they movetoward peaks 34).

Reference is made to FIG. 8, which is a schematic illustration of asystem 400, which comprises an implant 420, in accordance with someapplications of the invention. Implant 420 comprises a ring 422 and aplurality of anchors 424. Ring 422 comprises a plurality of strutsarranged in a pattern of alternating peaks 434 and troughs 436, e.g., asdescribed herein for other implants. Similarly to other implantsdescribed herein, implant 420 comprises an adjustment element 442 foreach pair of adjacent struts, e.g., disposed close to (e.g., at) eachpeak 434. In order to actuate (e.g., rotate) adjustment element 442, anadjustment tool is typically advanced through catheter 40 to theadjustment element. To facilitate guidance of the adjustment tool to theadjustment element, system 400 comprises a plurality of elongate guidemembers 450 (e.g., one for each adjustment element 442), coupled to ring422 close to (e.g., at) each peak 434, and extending proximally intocatheter 40. The adjustment tool is advanced along the elongate guidemember 450 to the adjustment element 442.

Implant 420 (and the other implants described herein, including implant20) are typically taller than annuloplasty rings known in the art, andtherefore peaks 434 and adjustment elements 442 are relatively highwithin atrium 6. For example, peaks 434 may be only a little inferiorto, at the same height as, or even superior to the site at whichcatheter 40 enters atrium 6 (e.g., the fossa ovalis). Each guide member450 is coupled to ring 422 (e.g., at a respective peak 434) via abearing 456. For example, and as shown, bearing 456 may be aball-and-socket bearing comprising a ball 454 (e.g., defined by implant420) and a socket 452 (e.g., coupled to, or defined by, a distal end ofthe guide member 450). Bearing 456 facilitates articulation between thedistal end of guide member 450 and implant 420, thereby allowingadjustment elements 442 to be positioned high within atrium 6, whilecoupled to the guide members.

Reference is made to FIGS. 9A-J, which are schematic illustrations of asystem 500, which comprises a plurality of subunits 502 that areintracorporeally assembled to form an implant 520, in accordance withsome applications of the invention. Once assembled, implant 520 issimilar to implant 20 and/or to another of the implants describedherein, mutatis mutandis. System 500 facilitates transfemoral deliveryof such an implant, by providing the implant as subunits 502, whichindividually have a smaller profile than that of a similar implant thatis delivered pre-assembled. Thus system 500 may be considered to be amodification of any of the implants described herein, and FIGS. 9A-J maybe considered to illustrate a technique for delivering such a modifiedimplant.

Each subunit 502 comprises a pair of struts that comprises a first strut532 (which has a first end-portion 532 a and a second end-portion 532 b)and a second strut 533 (which has a first end-portion 533 a and a secondend-portion 533 b). Each subunit defines a trough 536 at which thesecond end-portion of each strut of the pair is coupled to the secondend-portion of the other strut of the pair (i.e., end-portion 532 b iscoupled to end-portion 533 b).

A first subunit 502 a is transfemorally delivered to the native heartvalve (e.g., in a compressed state, within a catheter 540), typicallyinto an atrium such as the left atrium 6 of the heart (FIG. 9A).Subsequently, the trough 536 of subunit 502 a is anchored to tissue 10that surrounds the valve (e.g., tissue of the valve annulus) by drivinga tissue anchor 524 into the tissue, such as by using an anchor drivertool 504, which may be used to facilitate deployment of the subunit outof catheter 540 (FIGS. 9B-C).

Subsequently, first end-portion 533 a of second strut 533 of subunit 502a is secured to first end-portion 532 a of first strut 532 of anothersubunit 502 b, such that the secured first end-portions converge at anangle alpha_1 to define a peak 534 (FIGS. 9D-G). For example, and asshown, end-portion 533 a of first subunit 502 a may have an elongateguide member 506 attached thereto, the guide member extending proximallyfrom end-portion 533 a of the implanted subunit (e.g., into a deliverysheath, such as to outside of the subject), and end-portion 532 a ofsubunit 502 b is advanced over and along the guide member, guided by theguide member to end-portion 533 a of subunit 502 a. Subunit 502 b isanchored to tissue 10 in the same way as subunit 502 a.

Typically, an adjustment element 542 is subsequently coupled to thefirst end-portions that define each peak (FIG. 9G). For someapplications, this further secures these two end-portions to each other.For example, for applications in which adjustment element 542 comprisesa nut (e.g., as described hereinabove, mutatis mutandis), the nut istypically screwed onto the threads defined by the end-portions (e.g.,using a tool 508 that is reversibly coupled to the adjustment element,and is slidable over and along guide member 506), thereby securing theend-portions to each other.

Subsequently to the steps of anchoring and securing, the angle alpha_1defined by each peak 534 is reduced by actuating the adjustment element542 of that peak, e.g., using tool 508. This reduces a distance d4between anchors 524 of the adjacent subunits, thereby reducing thecircumference of a portion of the annulus of the valve being treated.The adjustment is shown in FIG. 9H in order to illustrate that theadjustment of each adjustment element 542 may be performed after eachsubunit 502 is secured. Alternatively, the adjustment may be deferreduntil after more than one (e.g., all) of the subunits have been secured(e.g., similarly to implant 20).

Following implantation, guide member 506 is typically decoupled fromimplant 520 and removed from the subject (FIG. 9I). This may be achievedby unthreading and/or cutting each guide member 506 (e.g., facilitatedby tool 508), or by any other suitable technique known in the art.

The above process is repeated iteratively, mutatis mutandis, untilimplant 520 has been fully assembled, e.g., formed into a full ring suchas that of implant 20, or into a partial ring or band (FIG. 9J).

The techniques described with reference to FIGS. 9A-J may be used toassemble implants similar to implants 20, 120, 220 and 320, mutatismutandis.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. Apparatus for use at a valve of a heart of a subject, the apparatus comprising an implant, the implant comprising: a ring, comprising (i) a plurality of struts arranged in a pattern of alternating peaks and troughs, and (ii) a plurality of hinges, the ring circumscribing a central axis, at least one hinge of the plurality of hinges being disposed at each trough, each strut having a first end-portion and a second end-portion, each peak defined by convergence of a pair of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of a pair of adjacent second end-portions; a plurality of adjustment elements, each of the adjustment elements being rotatably coupled to a respective pair of adjacent first end-portions such that rotation of the adjustment element with respect to the pair changes the angle at which the adjacent first end-portions of the pair are disposed with respect to each other; and a plurality of anchors, each anchor: having a longitudinal axis, configured to be driven along the longitudinal axis into tissue of the heart, and coupled to the ring at a respective trough via the at least one hinge in a manner that facilitates: movement of the anchor along the longitudinal axis with respect to the trough, and deflection of the longitudinal axis with respect to the central axis.
 2. The apparatus according to claim 1, further comprising at least one anchor driver, couplable to the plurality of anchors, and configured to anchor the ring to the heart by moving each anchor along its longitudinal axis with respect to its respective trough.
 3. The apparatus according to claim 1, further comprising at least one adjustment tool, reversibly couplable to the plurality of adjustment elements, and configured to rotate each adjustment element with respect to the respective pair of adjacent first end-portions.
 4. The apparatus according to claim 1, wherein each adjustment element circumscribes the respective pair of adjacent first end-portions.
 5. The apparatus according to claim 4, further comprising at least one adjustment tool, reversibly couplable to the plurality of adjustment elements, and configured to rotate each adjustment element around the respective pair of adjacent first end-portions.
 6. The apparatus according to claim 1, wherein each hinge couples the adjacent second end-portions to each other.
 7. The apparatus according to claim 1, wherein each hinge is a flexure bearing.
 8. The apparatus according to claim 1, wherein each hinge comprises a fabric.
 9. The apparatus according to claim 1, wherein each anchor is shaped and rotatably coupled to the ring at the respective trough such that rotation of the respective anchor with respect to the ring moves the anchor along its longitudinal axis with respect to the trough.
 10. The apparatus according to claim 1, wherein: the ring comprises a plurality of anchor mounts, at each trough: a respective anchor mount of the plurality of anchor mounts is articulatably coupled (i) to one second end-portion via a first hinge of the plurality of hinges, and (ii) to another second end-portion via a second hinge of the plurality of hinges, and the respective anchor is rotatably coupled to the respective anchor mount.
 11. The apparatus according to claim 10, wherein at each trough the respective anchor is rotatably coupled to the respective anchor mount such that rotation of the respective anchor with respect to the respective anchor mount moves the anchor along its longitudinal axis with respect to the anchor mount.
 12. The apparatus according to claim 1, wherein the implant is a zig-zag shaped implant, the zig-zag shape of the implant defined by the pattern of alternating peaks and troughs.
 13. The apparatus according to claim 1, wherein: the implant comprises exactly one ring comprising the plurality of struts arranged in the pattern of alternating peaks and troughs, and the exactly one ring defines all of the peaks of the implant and all of the troughs of the implant.
 14. The apparatus according to claim 1, wherein: the implant comprises exactly one ring comprising the plurality of struts arranged in the pattern of alternating peaks and troughs, the exactly one ring defines every trough of the implant, and every trough of the implant is coupled to a respective one of the anchors.
 15. The apparatus according to claim 1, wherein the implant is configured such that rotation of the adjustment element with respect to the respective pair of adjacent first end-portions screws the adjustment element over the pair, thereby changing the angle at which the adjacent first end-portions of the pair are disposed with respect to each other.
 16. The apparatus according to claim 1, wherein: the implant is configured to be delivered to the heart while in a compressed state, the implant is configured to automatically expand into an expanded state in which the implant has a circumference that is greater than in the compressed state, and each of the adjustment elements is rotatably coupled to the respective pair of adjacent first end-portions such that rotation within the heart of the adjustment element with respect to the pair contracts the implant toward its compressed state.
 17. A system comprising: an implant comprising a ring having a plurality of struts arranged in a pattern of alternating peaks and troughs, each strut of the plurality of struts having a first end-portion and a second end-portion, each peak defined by convergence of a pair of adjacent first end-portions disposed at an angle with respect to each other, and each trough defined by convergence of a pair of adjacent second end-portions, the ring circumscribing a central axis; a plurality of adjustment elements, each of the adjustment elements being rotatably coupled to a respective pair of adjacent first end-portions such that rotation of the adjustment element with respect to the pair changes the angle at which the adjacent first end-portions of the pair are disposed with respect to each other; and a plurality of anchors, each anchor: having a longitudinal axis, configured to be driven along the longitudinal axis into tissue of the heart, and coupled to the ring at a respective trough in a manner that facilitates: movement of the anchor along the longitudinal axis with respect to the trough, and deflection of the longitudinal axis with respect to the central axis. 